Technical Product Owner Small Molecule

Vor 2 Tagen

Zug, Schweiz Seagen Vollzeit

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us

Summary:
Principal Responsibilities:

- Work in collaboration with the Strategic Product Supply Lead (SPSL) to develop and execute Product Supply manufacturing strategies
- Be accountable for the provision of technical oversight for manufacturing activities for clinical and commercial manufacturing of Drug Linkers/SM API’s at CMO’s. Ensuring that manufacturing process are and remain aligned across manufacturing sites/CMOs
- Partner with the Internal/External Manufacturing Manager and the Quality Steward to ensure the robustness of the manufacturing process, product quality and continuity of supply
- Provide overall technical leadership for the Drug Linker manufacturing process working in close collaboration with MSAT SMEs
- Be accountable for the Technology Transfers into manufacturing facilities (internal or external). Review and write key technical elements of regulatory submissions and respond to agency requests for information
- Support the Drug Linkers/AM APIs throughout the 3 phases of Validation (Process Design, Process Qualification and Continuous Process Verification)
- Provide guidance for root cause investigations of process related deviations in a timely, comprehensive, and conclusive manner. Lead the data analysis of process data statistics, identify process deviations, assess product impact, prepare technical reports, and propose process solutions and improvements
- Provide guidance for comprehensive facility fit assessments and gap analysis for the relevant part of GMP manufacturing
- Work cross-functionally to support Development and Manufacturing as well as CMO’s in order to prepare User Requirement Specifications (URS) of novel process technologies and facility expansions/modifications to maintain state-of-the-art production meeting business needs
- Interface with Development and manufacturing sites for know-how transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements supporting next generation manufacturing processes. Identify and initiate process and procedural changes to improve process performance, robustness, productivity, safety, efficiency, and compliance
- Advise on Scientific and Business developments (including Technologies, Processes, Products, Input Materials, Regulations etc.). Support Due Diligence activities, CMO selections etc.
- Coach and share knowledge across Technical Operations

Qualifications:

- Extensive scientific and technical experience within relevant development and/or manufacturing technologies and unit operations relating to SM API/Drug Linker manufacturing. Experience with small and commercial scale equipment utilized in cGMP manufacturing facilities (including clinical manufacturing)
- Experience of senior technical leadership
- Good knowledge of structured methodologies for process design, scale-up/down models, process control strategies, process validation and continuous process verification
- The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency. Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams
- Experience working with Contract Manufacturing Organizations is required
- Able to effectively establish and maintain productive relationships with senior technical staff within and outside of Seagen
- Strong communication skills and computer literacy are essential
- Fluency in spoken and written English is mandatory
- Experience with innovation and operational excellence is desirable
- A good understanding of statistical analysis and continuous process verification is desirable

**Education**:

- An educational background in Chemistry, Chemical Engineering, or another relevant life-science discipline with industrial experience in the relevant process technologies, technology transfers, validation, GMP manufacturing and/or process optimization:

- BS and 12+ years of experience
- MS and 10+ years of experience
- PhD and 7+ years of experience

LI-CD1

  • Dp Product Owner

    Vor 2 Tagen

    Zug, Schweiz Kenvue Vollzeit

    **DP Product Owner**-2307010657W Description Kenvue part of Johnson & Johnson family of companies is recruiting for a Anaplan expert in Supply chain Plan **Kenvue - Part of the Johnson & Johnson Family of Companies**, is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most...

  • Value Chain Group Leader

    vor 1 Woche

    Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

    Janssen Supply Chain (JSC), is recruiting for a Value Chain Group Leader. Janssen Supply Chain is a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provide access and affordability through innovation and strong collaboration with their R&D and Commercial partners...

  • Product Owner

    vor 7 Monaten

    Zug, Schweiz Oliver James Associates Vollzeit

    Product Owner Software Development My client operates in the engineering and development space with a focus on new age technology. Your task will be to ensure the development and success of the software products. Ultimately, your goal is to maximize the business value of the solution. Your tasks As a key person in the team, you define the vision of this...

  • Ai Product Owner

    vor 2 Monaten

    Zug, Schweiz EcoDigital AG Vollzeit

    **Key Responsibilities**: **Technical**: - Formulate technical requirements and specifications, encompassing system architecture, computational capabilities, and software/hardware integration. - Collaborate with data scientists, architects, and engineers for feasibility assessments and technical planning. - Stay updated on emerging technologies in AI and...

  • Vp Partnership

    vor 8 Monaten

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson Innovative Medicine is recruiting for the position of VP Partnership & External Supply - Large Molecule. Reporting to the VP Manufacturing and Technical Operations, the Vice President, Partnerships & External Supply Integration of Large Molecule will lead the management of Innovative Medicine’s global external supply base. In this role...

  • Digital Product Owner

    Vor 7 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting for a Digital Product Owner - Strategic Portfolio Management (New Consumer Health Company). This position may be located in New Brunswick, NJ; Skillman, NJ; Zug, Switzerland; São José dos Campos, Brazil; Singapore (Science Park); or Remote. Caring for the world, one person at a time has inspired and united the...

  • Director, Order to Cash Product Owner

    Vor 3 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    **Director, OTC Product Owner**: **Description**: Johnson & Johnson Consumer Health Supply Chain is recruiting for a Director, OTC Product Owner located in Zug, Switzerland. Consumer Health is defining the future technology roadmap to support digital capabilities as the business spins off as a stand-alone company. As major programs evolve to deliver the...

  • Product Owner

    Vor 7 Tagen

    Zug, Schweiz ITech Consult Vollzeit

    **Product Owner **(f/m/d) - Analysis /Product Testing / Project Management / English / Scrum** **Project**: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified **Product Owner.** Background: Service Strategy & Innovation is focused on developing Roche Services further, excite with Customer Experience...

  • Product Manager/product Owner One Platform

    Vor 3 Tagen

    Zug, Schweiz Leica Geosystems AG - Part of Hexagon Vollzeit

    **Committed and with passion for precision we create digital reality solutions combining sensor, software, and autonomous technologies to empower a sustainable future.**: At Hexagon Mining Switzerland, we focus on collision-warning systems for large vehicles used mainly in open-pit mining. Hexagon Mining Safety products integrate satellite navigation,...

  • Product Owner Sap Neuwagensystem 80-100%

    vor 1 Tag

    Zug, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Product Owner Sap Neuwagensystem 80-100%

    vor 1 Tag

    Zug, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Product Owner SAP Neuwagensystem 80-100%

    vor 1 Tag

    Zug, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Lead Data Product Owner

    Vor 7 Tagen

    Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently recruiting a Lead Data Product Owner. This position may be located in New Brunswick, NJ; Skillman, NJ; Zug, Switzerland; São José dos Campos, São Paulo, Brazil; Singapore, and may have remote capabilities. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years....

  • Product Manager

    vor 7 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Projektleiter / Product Owner 80 - 100% (m/w)

    vor 1 Tag

    Zug, Schweiz yellowshark Vollzeit

    Zeit für was Neues? Die yellowshark AG bringt seit über 15 Jahren die richtigen Menschen in die richtigen Firmen. Nur eine Bewerbung reicht, um von unserem grossen Netzwerk zu profitieren.Aufgaben- Als Product Owner arbeitest du in einem Scrum-Team mit 5 bis 7 Personen und bist deren fachlicher Sparringpartner- Du sorgst dafür, dass die Anforderungen...

  • Product Manager Platform

    vor 7 Monaten

    Zug, Schweiz SHL Medical AG Vollzeit

    SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their...

  • Product Owner SAP Neuwagensystem 80-100%

    vor 1 Tag

    Zug ZG, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Product Owner SAP Neuwagensystem 80-100%

    vor 1 Tag

    Zug ZG, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Product Owner SAP Neuwagensystem 80-100%

    vor 24 Stunden

    Zug ZG, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...

  • Product Owner SAP Neuwagensystem 80-100%

    vor 22 Stunden

    Zug ZG, Schweiz AMAG Group AG Vollzeit

    Die AMAG Import AG ist mit den Marken Volkswagen, Audi, SEAT, CUPRA, Škoda und VW Nutzfahrzeuge der erfolgreichste Automobil-Importeur der Schweiz. Die Abteilung Business Process Analysis & Implementation erbringt Dienstleistungen in der Schnittstelle zwischen Business und IT mit dem Ziel, die Prozesse zwischen Hersteller, Importeur und Händlern...